Project FACTS (Fidelity Accuracy: Comparing Three Strategies)

NCT ID: NCT02820623

Last Updated: 2023-04-21

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2020-06-30

Brief Summary

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The objective is to compare the accuracy, costs, and cost-effectiveness of three fidelity measurement methods to assess fidelity to cognitive-behavioral therapy for youth. The investigators will randomize 135 therapists, implementing cognitive-behavioral therapy, to 3 conditions: self-report, chart stimulated recall, and behavioral rehearsal (N = 45 for each group). To calculate the outcomes of interest, each condition will be compared to the gold-standard fidelity measurement method, direct observation.

Detailed Description

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To achieve the primary objective, the investigators plan to (1) identify the most accurate fidelity measurement method; (2) estimate the economic costs and cost-effectiveness of the fidelity measurement methods; and (3) compare stakeholders' motivation to use each method, as well as identify their perceived barriers and facilitators to use of each method. This study will have a significant positive impact in two ways. First, it will validate fidelity measurement methods that can be used for research. Second, it will produce tools that can be used by community mental health clinics to monitor therapist fidelity, an indicator of therapy quality.

Conditions

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Assess Fidelity to Cognitive-behavioral Therapy for Youth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Self-report

Therapists randomized to this condition will complete a brief self-report measure, the Therapy Process Observational Coding System for Child Psychotherapy Strategies Scale-Self Report version (TPOCS-SR) for each of the recorded clinical encounters with enrolled youth. The TPOCS-SR will be a self-report version of the Therapy Process Observational Coding System for Child Psychotherapy-Strategies Scale (TPOCS-S) and will be created in collaboration with the instrument developer (McLeod). In this condition, the investigators will (a) provide an operational definition for each item on the TPOCS-SR (e.g., cognitive education: teaches client the cognitive model (e.g., thoughts influence behavior)/identifies how the cognitive model applies to a specific aspects of the client's life), and (b) provide therapists with a 30-minute training session that includes sample vignettes of particular behaviors and information about how those vignettes should be rated.

Group Type EXPERIMENTAL

Self-report

Intervention Type BEHAVIORAL

Chart Stimulated Recall

Therapists randomized to this condition will be asked to bring the charts of three enrolled youth to the chart-stimulated recall interview. A trained interviewer will ask the therapists how well they recall the encounter (rating of memory quality) followed by an open-ended question ("Talk me through your last session with your client. Tell me what you did."). While the therapists are speaking, the interviewer will note any elements that represent a prescribed CBT strategy. The interviewer will go through a list of cognitive-behavioral strategies based upon the TPOCS-S and probe to determine if the therapists completed any of the strategies. Follow-up questions will be used to explore to what degree an element was used and how skillfully and responsively the strategies were used.

Group Type EXPERIMENTAL

Chart-Stimulated Recall

Intervention Type BEHAVIORAL

Behavioral Rehearsal

Therapists randomized to this condition will be asked to engage in role-plays demonstrating the CBT strategies used with the three enrolled youth. The investigators will provide therapists with a list of the TPOCS-S CBT strategies and ask them to identify the CBT strategies used in their recorded encounter. The investigators will randomly select one of the strategies they report for each role-play. The investigators will then tell them, "Please role-play how you used this strategy in session with your client, with the trained actor in front of you." Later, an independent rater will rate therapists' adherence and skill based on established scoring criteria.

Group Type EXPERIMENTAL

Behavioral Rehearsal

Intervention Type BEHAVIORAL

Interventions

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Self-report

Intervention Type BEHAVIORAL

Chart-Stimulated Recall

Intervention Type BEHAVIORAL

Behavioral Rehearsal

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* they provide mental health treatment services in community mental health agencies in the City of Philadelphia participating in this study and

* have been trained in cognitive-behavioral therapy (CBT) through the City-sponsored CBT evidence-based practice initiatives, and/or
* respond to a brief screening survey that they use CBT; and/or
* are nominated by a supervisor as a therapist who uses CBT.


* they are supervisors or administrators (i.e., they hold leadership positions) in community mental health agencies in the City of Philadelphia participating in this study.


* Youth and their legal guardians will be eligible to participate in this study if the youth

* is 3-24 years old and
* has completed at least one session with a therapist who has enrolled to participate in this study.

Exclusion Criteria

* n/a


* n/a


* if the child does not have a legal guardian who is able to consent (e.g., the Department of Human Services (DHS) is the guardian).
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Rinad Beidas

Ralph Seal Paffenbarger Professor and Chair, Department of Medical Social Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rinad S Beidas, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Emily M Becker-Haimes, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

References

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Becker-Haimes EM, Marcus SC, Klein MR, Schoenwald SK, Fugo PB, McLeod BD, Dorsey S, Williams NJ, Mandell DS, Beidas RS. A Randomized Trial to Identify Accurate Measurement Methods for Adherence to Cognitive-Behavioral Therapy. Behav Ther. 2022 Nov;53(6):1191-1204. doi: 10.1016/j.beth.2022.06.001. Epub 2022 Jun 10.

Reference Type DERIVED
PMID: 36229116 (View on PubMed)

Beidas RS, Maclean JC, Fishman J, Dorsey S, Schoenwald SK, Mandell DS, Shea JA, McLeod BD, French MT, Hogue A, Adams DR, Lieberman A, Becker-Haimes EM, Marcus SC. A randomized trial to identify accurate and cost-effective fidelity measurement methods for cognitive-behavioral therapy: project FACTS study protocol. BMC Psychiatry. 2016 Sep 15;16(1):323. doi: 10.1186/s12888-016-1034-z.

Reference Type DERIVED
PMID: 27633780 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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Other Identifiers

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R01MH108551

Identifier Type: NIH

Identifier Source: org_study_id

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